Data Coordination and Biostatistics Center for the NORDIC Network

北欧网络数据协调和生物统计中心

• 批准号: 7883774
• 负责人: KARL D. KIEBURTZ
• 金额: $ 70万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-02-10 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7883774
• 关键词: Address; Affect; Applications Grants; Biometry; California; Canada; Case Report Form; Childhood; Clinical; Clinical Research; Clinical Trials; Collaborations; Collection; Companions; Consent; Contracts; Data; Data Collection; Data Coordinating Center; Databases; Dental; Development Plans; Disease; Drug Formulations; Drug Monitoring; Electronics; Enrollment; Environment; Event; Futility; Future; Generations; Health; Human Resources; Individual; Informed Consent; Instruction; Internet; Label; Laboratories; Maintenance; Manuals; Modeling; Modification; Monitor; N.I.H. Research Support; Observational Study; Online Systems; Operative Surgical Procedures; Ophthalmology; Pharmaceutical Preparations; Photography; Play; Preparation; Prevention; Procedures; Protocols documentation; Public Health; Publications; Randomized; Randomized Clinical Trials; Randomized Controlled Clinical Trials; Reading; Reporting; Research; Research Infrastructure; Research Personnel; Research Project Grants; Research Proposals; Research Subjects; Research Support; Resolution; Role; Safety; Sampling; Secure; Series; Serious Adverse Event; Services; Site; System; Technology; Teleconferences; Therapeutic; Training; Universities; Vendor; Visual Fields; Withdrawal; Writing; base; data management; design; experience; meetings; nervous system disorder; premature

DESCRIPTION (provided by applicant): This grant application is a companion to the application submitted by Dr. Mark Kupersmith for the Neuro-Ophthalmology Research Disease Investigator Consortium (NORDIC). This application describes a Data Coordination and Biostatistics Center (DCBC), a Visual Field Reading Center (VFRC) and a Photography Reading Center (PRC) that together will provide the crucial infrastructure for the conduct of the NORDIC projects described in Dr. Kupersmith's application. The functions of the VFRC and PRC are detailed in the attached individual applications. The DCBC will provide all project coordination, data management and biostatistical collaboration for all NORDIC projects. DCBC personnel will play a central role in the formulation of each project including: refining study hypotheses and analytic plans; concretizing the project in a study protocol, manual of procedures, and model informed consent; and developing an integrated data management plan. Additional project coordination tasks include: obtaining and maintaining appropriate approvals from applicable regulatory agencies (e.g., FDA, Health Canada) as necessary; identification and collection of relevant regulatory documents; training of site personnel; study drug procurement, packaging and distribution; tracking and reporting study events, contracting with and managing other vendors needed in NORDIC projects (e.g., central laboratory). Additional data management activities include: developing and providing access to electronic Case Report Forms (eCRFs); training sites in the use of electronic web-based data capture system from eResearch Technology; tracking and cleaning project databases; and generating reports of data collection timeliness and accuracy. Additional biostatistical activities include conducting final analyses and contributing to study publications; liaising with the DSMC for report generation; and conducting and reporting secondary and exploratory analyses. The clinical and biostatistical personnel of the DCBC have successfully collaborated for over >15 years on dozens of multicenter clinical research projects. This experience will support the successful conduct of NORDIC projects. The creation of the NORDIC Network with the DCBC, VFRC, and PRC is significant from a public health standpoint in that it provides the essential infrastructure to perform wide reaching prospecitve research that will properly evaluate potential treatments in neuro-ophthalmalogic disorders that collectively affect millions of people.

描述（由申请人提供）：此资助申请是Mark Kupersmith博士提交的神经眼科研究疾病研究者联盟（NORDIC）申请的伴侣。该申请描述了一个数据协调和生物统计中心（DCBC），一个视野阅读中心（VFRC）和一个摄影阅读中心（PRC），它们将共同为Kupersmith博士申请中描述的NORDIC项目的开展提供关键的基础设施。自愿财务审查委员会和审查委员会的职能详见所附的个别申请。DCBC将为所有NORDIC项目提供所有项目协调、数据管理和生物统计合作。DCBC人员将在每个项目的制定中发挥核心作用，包括：完善研究假设和分析计划;在研究方案、程序手册和知情同意模型中具体化项目;以及制定综合数据管理计划。其他项目协调任务包括：获得并维护相关监管机构的适当批准（例如，FDA、加拿大卫生部）;识别和收集相关监管文件;培训研究中心人员;研究药物采购、包装和分发;跟踪和报告研究事件，与NORDIC项目所需的其他供应商签订合同并进行管理（例如，中心实验室）。其他数据管理活动包括：开发和提供电子病例报告表（eCRF）的访问权限;培训研究中心使用eResearch Technology的基于网络的电子数据采集系统;跟踪和清理项目数据库;以及生成数据收集及时性和准确性报告。其他生物统计活动包括进行最终分析和撰写研究出版物;与DSMC联系以生成报告;以及进行和报告次要和探索性分析。DCBC的临床和生物统计人员在数十个多中心临床研究项目上成功合作超过15年。这一经验将有助于成功实施北欧信息技术公司的项目。从公共卫生的角度来看，与DCBC，VFRC和PRC建立NORDIC网络具有重要意义，因为它提供了进行广泛前瞻性研究的必要基础设施，这些研究将正确评估集体影响数百万人的神经眼科疾病的潜在治疗方法。